Quality Business Process Lead – Boston Scientific – Kerkrade

Boston Scientific

About the role:

Collaborates with Quality management to recommend, design and implement functional process improvements. Develops, establishes and maintains quality methodologies, systems and practices which meet BSC, customer and regulatory requirements.

The Quality Business Process Lead serves as a Quality representative for our Data analytics, Quality metric reporting and management process. Partner with the Global Systems Project Team to, supporting Quality Systems information needs for surveillance of product performance.

Additional activities include: identifying products affected by non-conformance issues, Hold Notices (Quality Notification System – QNS), Product Inquiry Report data generation and Field Action data acquisition/execution. Overall objective is to support the process of providing support for effective management of quality system information to meet the Quality System’s requirements of Boston Scientific

Location Onsite : 4- 5 days onsite in Kerkrade-The Netherlands 

Your responsibilities will include:

  • Understands and applies quality principles to support an effective overall quality system. 
  • Collaborates with cross-functional colleagues regarding the impacts of enhancements and process changes within BSC.
  • Experience with writing and reviewing of Change Controls, Non-Conformances, CAPAs
  • Supports Field action process when requested. 
  • Takes the lead in quality notifications and associated activities.
  • Data Collection, analytics and trending capabilities.
  • Kerkrade SME for community of Practice forum (COP) as representative of Kerkrade ECO, share all relevant information with team.
  • Review redeployments and training of new QE’s in the process.
  • Creating and management of dashboards in Tableau and Alteryx. 
  • Act as a team member in NCEPs, CAPA and lean initiatives from a quality perspective, for both internal and external customers.
  • Pro-actively investigates, identifies and implements best in class Quality Engineering practices and implements/manages improvement projects within the organization (CI, Lean, 5S).
  • Understands and utilizes problem solving methodologies; (CAPA, Is/Is not diagram/Fishbone diagram, Pareto, FMEA).
  • Providing support for effective management of quality system metrics by collating the data to support the monthly metrics. 
  • Performs quality approval on software validation processes in Kerkrade. 
  • Flexibility to perform general QA related activities.
  • Drives awareness and compliance with applicable standard operating procedures to meet, comply and champion all quality and regulatory commitments of Boston Scientific.
  • Support and prepare for site level internal and external audits and act as Subject Matter Expert (SME) in audits when needed. 
  • Who are we looking for:

  • 3+ years’ experience with bachelor’s degree or equivalent
  • Comprehensive understanding of the Quality system regulation (QSR), cGMP and ISO/MDD standards
  • Advanced excel capabilities.
  • Advanced SAP working knowledge.
  • Knowledge of distribution processes incl. inventory management, inbound, outbound, Localization would be preferable.
  • Strong analytical skills, eager to improve and results oriented.
  • Strong knowledge of the English language (verbal and written)
  • Good social and communication skills
  • Requisition ID:  575708

    As a leader in medical science for more than 40 years, we are committed to solving the challenges that matter most – united by a deep caring for human life. Our mission to advance science for life is about transforming lives through innovative medical solutions that improve patient lives, create value for our customers, and support our employees and the communities in which we operate. Now more than ever, we have a responsibility to apply those values to everything we do – as a global business and as a global corporate citizen.

    So, choosing a career with Boston Scientific (NYSE: BSX) isn’t just business, it’s personal. And if you’re a natural problem-solver with the imagination, determination, and spirit to make a meaningful difference to people worldwide, we encourage you to apply and look forward to connecting with you!

    Lees hier meer

    Deel deze vacature: